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Evidence-Based Oncology February 2016
Immuno-Oncology 2016 and Beyond: The Opportunities, Challenges, and Risks
Michael V. Seiden, MD, PhD
Where Does Immuno-Oncology Fit in a Value-Based Care Delivery Model?
Bruce Feinberg, DO
The Fight of Our Lives: Confronting the Unmet Need in Lung Cancer
Bonnie J. Addario
Evolving Practices in Managing Costly Immunotherapy
Carina Verdier Dolan, PharmD, BCOP
Access to Immuno-Oncology Therapies - European Policy Perspective
Suzanne Wait, PhD
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Patient Access to Immuno-Oncology Agents - A US Policy Perspective
Surabhi Dangi-Garimella, PhD
Shaping the Future of Immuno-Oncology
Joseph Alvarnas, MD
Cancer MoonShot 2020 Proposes a Collaborative Precision Cancer Care Model
Surabhi Dangi-Garimella, PhD
FDA Update in Oncology, February 2016
Surabhi Dangi-Garimella, PhD
Managed Care Updates in Oncology, February 2016
Surabhi Dangi-Garimella, PhD

Patient Access to Immuno-Oncology Agents - A US Policy Perspective

Surabhi Dangi-Garimella, PhD
The cost issues with immuno-oncology agents are real, but so is the value that they bring to the table. How can we improve access to these agents at a reasonable cost?
Developments in the field of immuno-oncology (I-O) have ushered in a new era of hope in cancer care. This new concept has forced scientists and clinicians to think beyond the organ of origin of the tumor and wonder about the dynamic interaction between the tumor and its environment.  
A significant advantage of I-O, unlike chemotherapy or some of the targeted agents, is the lasting memory created by immunomodulatory drugs on the individual’s immune system. The idea of targeting the host’s immune system evolved from an improved understanding of cancer—the realization that cancer is not an individual disease arising from a single, clonal cell harboring mutations—but rather, cancer can be defined as multiple diseases with a systemic rather than a clonal origin.
The History
Pioneering work by cancer surgeon, William B. Coley, who demonstrated the importance of activating the immune system in a cancer patient (by injecting a live culture of bacteria into the tumor), generated clues leading to the important discovery of the immune system’s role in cancer.1 Subsequent animal models documented tumor rejection, rather than tumor immunity, which misled scientists resulting in a loss of faith in tumor immunology, until the development of the syngeneic mouse model—where tumors were derived from mice with the same genetic background. This subsequently laid the groundwork for the important role of immune surveillance in cancer.2
The entire immune system participates to help defend the body from the tumor; this includes innate immunity initiated by a cacophony of natural killer cells or NK cells, macrophages, dendritic cells, T- and B cells, and cytokines. The adaptive immune system, which includes the CD4+ helper T cells, CD8+ cytotoxic T cells, and antibodies, help with the complete elimination of the tumor and help develop the body’s immune memory against tumor components to prevent tumor recurrence.3
The armamentarium of immune defense against cancer has been growing: monoclonal antibodies, tumor vaccines, CAR-T or chimeric antigen receptor-T cells, and the new stream of immune activators. An overview of recent progress with the new I-O agents, including programmed death 1 (PD-1), programmed death-ligand 1 (PD-L1), and cytotoxic T-lymphocyte–associated protein 4 (CTLA-4), can be found here. Overall, these agents have been deemed game changers in oncology care, alone or in combination, over the standard of care.
So far, FDA approvals have been restricted to melanoma, non–small cell lung cancer, and renal cell carcinoma, but numerous studies are testing these agents in a variety of solid, as well as, liquid tumors.
And the Issue Seems to Be?
There’s little question that the cost of these drugs, and the resulting copayments and high deductibles, will be a barrier to patient access. Over the years, the oncology drug cost increase has had a steep slope. Given that some of the new drugs provide significant survival outcomes (months, instead of weeks); however, cancer drugs averaged at less than $10,000 annually prior to 2000, while 12 of 13 anticancer agents approved in 2012 were priced over $100,000 annually.4 Ipilimumab, a CTLA-4 inhibitor developed by Bristol-Myers Squibb and approved for treatment of patients with advanced melanoma, costs $130,000 for a 12-week course. Nivolumab, developed by the same company is estimated to cost $150,000 annually ($12,500 per month). Pembrolizumab, developed by Merck, costs the same.5  
High Patient Cost-Sharing
Financial toxicity, in oncology, is not a new phenomenon. In the December 2015 issue of Evidence-Based Oncology, we heard from patients, patient advocacy groups, and health policy experts about the economic impact of cancer, in addition to the physical and emotional cost, on the patient and their family. A recent study in 100 insured patients, who were already receiving treatment for multiple myeloma, between August 2014 and January 2015, found that:
  • 59% of patients were surprised by the cost of their care
  • 71% felt a small amount of financial burden
  • 36% applied for assistance to pay their bills6
Another study, investigating the financial outcomes of 550 colon cancer patients, found nearly 40% of patients reported experiencing at least one of the following, after cancer diagnosis:
  • Borrowing money from family or friends
  • A minimum of 20% income decline
  • Accrual of debt
  • Selling their primary residence7
How Can We Improve Patient Access to These Treatments?

The cost issues are real, but so is the value that the new anticancer treatments bring to the table. If not “cure,” I-O, at the least, has the potential to transform the discussion on cancer outcomes into one of a chronic disease, similar to what the newer treatments have done for hepatitis C.

We need a multi-faceted approach to help patients gain access to I-O and future revolutionary oncology treatments. To guide policy changes, policy makers in Europe have formed the European Expert Group on Immuno-Oncology to encourage rapid and appropriate access to I-O therapies across Europe. You can read more on the group’s proposed framework here.

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